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A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: protocol for the ASPREE-Fracture substudy
  1. Anna L Barker1,
  2. John J McNeil1,
  3. Ego Seeman2,
  4. Stephanie A Ward1,3,
  5. Kerrie M Sanders4,5,
  6. Sundeep Khosla6,
  7. Robert G Cumming7,
  8. Julie A Pasco4,8,
  9. Megan A Bohensky9,
  10. Peter R Ebeling10,
  11. Robyn L Woods1,
  12. Jessica E Lockery1,
  13. Rory Wolfe1,
  14. Jason Talevski1
  15. and the ASPREE Investigator Group
  1. 1Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
  2. 2Department of Endocrinology and Medicine, Austin Health, University of Melbourne, Melbourne, Australia
  3. 3Monash Ageing Research Centre (MONARC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
  4. 4Department of Medicine, NorthWest Academic Centre, University of Melbourne, Melbourne, Australia
  5. 5Institute for Health and Ageing, Australian Catholic University, Melbourne, Australia
  6. 6Endocrine Research Unit, College of Medicine, Mayo Clinic, Rochester, USA
  7. 7School of Public Health, University of Sydney, Sydney, Australia
  8. 8Epi-Centre for Healthy Ageing, School of Medicine, Deakin University, Geelong, Australia
  9. 9Department of Medicine, Melbourne EpiCentre, University of Melbourne, Melbourne, Australia
  10. 10Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Australia
  1. Correspondence to A/Prof Anna Barker, DEPM, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia; anna.barker{at}monash.edu

Abstract

Background Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. Observational studies suggest that aspirin may reduce fracture risk. While these studies provide room for optimism, randomised controlled trials are needed. This paper describes the rationale and design of the ASPirin in Reducing Events in the Elderly (ASPREE)-Fracture substudy, which aims to determine whether daily low-dose aspirin decreases fracture risk in healthy older people.

Methods ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment using low-dose aspirin extends the duration of disability-free and dementia-free life in 19 000 healthy older people recruited from Australian and US community settings. This substudy extends the ASPREE trial data collection to determine the effect of daily low-dose aspirin on fracture and fall-related hospital presentation risk in the 16 500 ASPREE participants aged ≥70 years recruited in Australia. The intervention is a once daily dose of enteric-coated aspirin (100 mg) versus a matching placebo, randomised on a 1:1 basis. The primary outcome for this substudy is the occurrence of any fracture—vertebral, hip and non-vert-non-hip—occurring post randomisation. Fall-related hospital presentations are a secondary outcome.

Discussion This substudy will determine whether a widely available, simple and inexpensive health intervention—aspirin—reduces the risk of fractures in older Australians. If it is demonstrated to safely reduce the risk of fractures and serious falls, it is possible that aspirin might provide a means of fracture prevention.

Trial registration number The protocol for this substudy is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000347561).

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